Breast Implants Linked to Squamous Cell Carcinoma and Lymphoma in the Capsule, FDA Warns

Women who received breast implants may face an increased risk of squamous cell carcinoma and various lymphomas, which have been found in scar tissue capsules surrounding implants, according to a warning issued by federal health officials.

Estimates suggest that between one million and three million women in the United States have received breast implants, with about 60% of the procedures done for cosmetic reasons, since the implants are generally believed to be safe and carry few, if any, serious side effects.

In recent years concerns have emerged about a breast implant cancer risk, known as breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), which is a rare form of lymphoma that can develop in the tissue surrounding certain types of implants, primarily with textured surface areas. However, a new warning raises concerns about a different type of cancer linked to breast implants.

Breast Implants Lymphoma and Squamous Cell Carcinoma Risks

The U.S. Food and Drug Administration (FDA) issued a breast implant safety communication on September 8, indicating it has received reports of squamous cell carcinoma (SCC) and other lymphomas occurring in breast tissue capsules around implants through postmarketing reports.

The agency indicates that, as of September 1, it has received 22 reports of various lymphomas tied to breast implants, including 10 reports of squamous cell carcinoma; a form of skin cancer. However, these breast implant cancers were different from the BIA-ALCL cases, which have resulted in prior warnings.

Squamous cell carcinoma is the second most common form of skin cancer, which causes abnormal squamous cell growth. It often appears as red, scaly patches, sores, and thickened wart-like skin which can bleed, itch, crack and crust over. It can often be easily treated if caught early, but can be disfiguring and deadly if diagnosis and treatment are delayed. An estimated 1.8 million SCC cases are diagnosed each year, and the incidence rate has doubled over the last 30 years, health experts warn.

Lymphomas are an entire class of cancer, also known as lymphatic cancer, which comes in many forms, but all of which attack the body’s lymphatic system. The main types are Hodgkin’s lymphoma and non-Hodgkin’s lymphoma, but the types, expressions, treatments, and prognoses and rarity can vary greatly among its many different forms.

In an accompanying press release, FDA officials noted that such cancers appear to be rare, but felt they were something of which the public, and medical community, should be made aware.

“In some reported cases, patients were diagnosed years after having breast implants and presented with findings such as swelling, pain, lumps or skin changes,” the FDA press release states. “These emerging reports of lymphoma in scar tissue are different from Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), which the FDA began communicating about as a potential risk more than a decade ago.”

In October 2021, the FDA required breast implant manufacturers to add a prominent “boxed” warning designed to alert patients to the risk of breast implant ALCL. However, the agency indicates that these SCC and lymphoma cases are a separate issue, and the agency is still trying to determine the level of risk for breast implant recipients, many of whom receive the implants following removal of one of both breasts as part of breast cancer treatment. This new warning indicates receiving such implants may be putting them at increased risk of cancer yet again.

“Right now, we do not have enough information to say whether breast implants cause these cancers or if some implants pose higher risk than others,” the FDA press release states. “For this reason, instances of SCC, lymphoma and any cancer located in the scar tissue around breast implants should be reported to the FDA. Our collective understanding has advanced significantly because of the efforts to study, communicate and act when needed.”

To date, reports have involved textured and smooth breast implants made from both silicone and saline. Many reported development of lymphomas after having breast implants for years with no problems. The most commonly reported symptoms appear to be swelling, pain, lumps or skin changes.

The FDA recommends those who have, or are considering, breast implants be aware of the risks and reports of lymphomas and carcinomas, regularly monitor their breast implants for abnormal changes and immediately alert their health care provider if such signs are present. The FDA is not recommending breast implant removal if there are no symptoms.

Health care providers are advised to provide routine care and support to patients with breast implants, to be aware of cases of SCC and various lymphomas linked to the capsule surrounding breast implants, to carefully examine breast implant specimens for all findings and potential diagnoses and to report cases of SCC, lymphomas or other breast implant- related health problems to the FDA’s MedWatch adverse event reporting program.

Breast Implant ALCL Lawsuits

Following warnings about the risk of anaplastic large cell lymphoma (ALCL) among breast implant recipients, federal health officials launched a prior investigation to determine the cause and found that most of the problems were linked to large, textured surface areas.

Allergan issued a breast implant recall for its textured Biocell implants in 2019, after the FDA warned that the design was linked to nearly all cases of BIA-ALCL. Since then, doctors have determined removing the implants is the best means of treating BIA-ALCL in most cases, but the manufacturer continues to refuse to pay for women to have the recalled breast implants removed.

Since the recall, there has been hundreds of breast implant ALCL lawsuits, each raising similar allegations that Allergan sold unreasonably dangerous and defective textured implants, without warning women about the potential risks.